新旧《药品不良反应报告和监测管理办法》对比分析  

A Comparative Analysis Between the New Version of Measures for the Reporting and Monitoring of Adverse Drug Reactions and the Original One

作　　者：侯永芳[1] 王丹[1] 田春华[1] 王玲[1] 杜晓曦[1] 

机构地区：[1]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药事》2011年第11期1075-1078,1088,共5页Chinese Pharmaceutical Affairs

摘　　要：目的探讨新《药品不良反应报告和监测管理办法》的先进性。方法从监管部门职责、不良反应报告和监测过程各个环节,对比分析《药品不良反应报告和监测管理办法》修订前后的差异,阐述其实施的重要意义。结果与原法规比较,新法规明确了省以下监管部门和监测机构的职责,细化、规范了不良反应报告要求,完善、强化了评价与控制措施,引入重点监测,使不良反应被动监测变为主动、被动相结合。结论新法规为及时、全面获取药品不良反应相关信息、科学评价药品安全性问题、有效控制药品风险提供了有力保障。Objective To probe into advancement of new Measures for the Reporting and Monitoring of Adverse Drug Reactions（hereinafter referred to as Measures）.Methods To compare and analyze differences between two versions of Measures,referring to the responsibilities of regulatory authorities and supervisory agencies and all aspects of the reporting and monitoring progress of adverse drug reaction,elaborating the significance of the new Measures implementing.Results comparing with the original Measures,the new one clearly indentified the responsibilities of regulatory authorities and monitoring angencies below the provincial levels,refined and standardized the requirements related to adverse reactions reporting,improved and strengthened the evaluation and control measures,introduced the key monitoring and thus changed the passive monitoring into the active and passive integration.Conclusion The new Measures provide a strong guarantee for the timely and comprehensive access to information about adverse drug reactions,the scientific evaluation of drug safety issues,and the effective control of drug risks.

关 键 词：药品不良反应 报告 管理办法 对比 

分 类 号：R95[医药卫生—药学]